Clinical Trial Page

Summary
EudraCT Number:2004-001190-25
Sponsor's Protocol Code Number:A6291015
National Competent Authority:Denmark - DHMA
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2008-07-09
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedDenmark - DHMA
A.2EudraCT number2004-001190-25
A.3Full title of the trial
A Double-blind, Proof of Concept Trial of the use of Pegvisomant to Reduce Urinary
Albumin excretion in Type 1 and Type 2 Diabetic Patients treated with Angiotensin Convertase Inhibitors/Angiotensin receptor blockers, with persistent Albuminuria.
A.3.2Name or abbreviated title of the trial where available
N/A
A.4.1Sponsor's protocol code numberA6291015
A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorPfizer ApS
B.1.3.4CountryDenmark
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameSomavert
D.3.2Product code PN-800,467
D.3.4Pharmaceutical form Powder for solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPegvisomant
D.3.9.2Current sponsor codePN-800,467
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number10
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Yes
D.3.11.13.1Other medicinal product typerecombinant DNA product
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboPowder for solution for injection
D.8.4Route of administration of the placeboSubcutaneous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Diabetic nephropathy DN (Diabetes mellitus (DM) type I and type II with renal manifestations).


MedDRA classification code : 10061835, 10045236 and 10045250 (Version 7.0, Level LLT)
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To establish that Pegvisomant causes a clinically meaningful decrease in urinary albumin creatinine ratio (UACR) beyond that provided by ACEIs and ARBs.

A clinically meaningful decrease is defined as either a 30% average decrease in UACR or a significant percentage of subjects (≥70%) showing a 30% decrease in UACR.
E.2.2Secondary objectives of the trial
To demonstrate improvements in renal function and glycaemic control.

To demonstrate the safety of pegvisomant in the treatment of subjects with diabetic nephropathy.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
1.Male and female subjects between the ages of 18-70 years, with Type 1 or Type 2 DM and persistent albuminuria UACR ≥ 3 mg/ mmol.
2.Stable treatment with ACEI or ARB for at least 6 months.
3.Serum creatinine 88-265 µmol/L (1.0-3.0 mg/dL) or GFR≥ 30 ml/min.
4.Subject must be willing to perform regular home blood glucose monitoring according to local clinical practice.
5.Subject must be willing and able to provide informed consent.
6.Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other programme procedures.
E.4Principal exclusion criteria
1. Additional biopsy-proven renal pathology to DN.
2. Untreated proliferative diabetic retinopathy, as assessed in the clinic.
3. Combined ACEI/ARB treatment.
4. Uncontrolled hypertension BP ≥160/90, despite treatment with 3 anti-hypertensive medications.
5. Proteinuria ≥ 5g/24 hr.
6. Labile glycaemic control as assessed by the trial investigator.
7. Recurrent hypoglycaemia and loss of hypoglycaemic awareness.
8. Other conditions that may result in abnormal GH and/or IGF-1 concentrations (e.g. acromegaly, severe hepatic disease, malnutrition (BMI ≤ 18), morbid obesity (BMI ≥40), treatment with levodopa).
9. Secondary diabetes mellitus (e.g. thalassaemia major, cystic fibrosis, Cushing’s syndrome).
10. Oral or parenteral steroid treatment ongoing, or for longer than 6 weeks within last 3 months of trial.
11. Serum ALT and, or AST ≥ 5x ULN, or clinically significant hepatic disease.
12. History of relevant drug and/or food allergies or are on regular treatment with any medication that might be expected to interfere with projected programme results.
13. Female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the programme.
14. Participation in another clinical trial in the last 6 months.
15. Subjects who have donated blood during the previous month or intend to donate blood or blood products during the trial, or for one month following the completion of the trial.
16. Known or suspected alcohol or drug abuse.
17. Female who is or may be pregnant or is lactating.
18. Subject has known or suspected latex allergy.
19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
E.5 End points
E.5.1Primary end point(s)
Proportion of subjects whose UACR fell by ≥ 30% from baseline to 24 weeks.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Information not present in EudraCT
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Yes
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Yes
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States Yes
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee Information not present in EudraCT
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months9
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-07-09. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state60
F.4.2 For a multinational trial
F.4.2.1In the EEA 138
F.4.2.2In the whole clinical trial 180
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
As expected normal treatment
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-11-16
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-02-21
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2006-03-12

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